- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Reason for recall
- The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
- Affected products (lot / model / serial)
- Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;
- Units affected
- 75 units
- Distribution pattern
- US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
- Firm location
- Norderstedt, Germany
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1651-2026
- Recall initiated
- February 11, 2026
- FDA classification date
- March 26, 2026
- FDA report date
- April 1, 2026
- FDA event ID
- 98431
- Last updated on HTM Vibe
- July 24, 2026